Its spokeswoman said Article 50 of the Treaty on the Functioning of the EU sets out the procedure to be followed in case a Member States notifies the European Council of its decision to withdraw from the Union.

She added: “No country has ever decided to leave the EU, so there is no precedent for this situation.

“It is too early to foresee the implications of this decision and we will be in close contact with the EU institutions. When we have concrete information, we will share it with our stakeholders.

“EMA will continue with its work with the goal to protect human and animal health and ensure access to medicines that are safe, effective and of good quality.”